Kornimate/medical-research-clean huggingface dataset:
the exopulse mollii suit study - a database for routine follow-up of clinical outcomes

Conditions: Cerebral Palsy; Multiple Sclerosis; Stroke; Spinal Cord Injuries; Neurologic Disorder

Summary: the objective is to explore the potential short and long-term impact of the exopulse mollii suit on subjects with cp, ms, stroke, sci or other neurological disorders which may cause such types of symptoms, and to identify high responders among the sub-categories of the diagnoses. the primary endpoint will be improvement on the berg/pediatric balance scale (bbs) as a measurement of balance and risk of falls.

the registry is designed to demonstrate the impact of exopulse mollii suit on improvement and relaxation of muscles, muscle activation, local blood circulation and chronic pain relief. the subjects will serve as their own control and the data will be collected before, during and after the treatment period. as the electrical stimulation from the suit usually is above the level of sensation, the study participant cannot be blinded to the treatment. to prevent bias, multiple investigators will be collecting the data and only standardized and validated methods will be used. all investigators will be trained on the measurements prior to the registry start. additionally, all investigators are trained and certified in the exopulse method, and the generic stimulation settings are selected according to a standardized matrix based on the subjects' age and level of impairment. re-assessments during scheduled visits are part of normal routine and use. the decision whether the subjects will be enrolled in the registry is separated from the subject's decision to use the device.

Eligibility criteria:
inclusion criteria: * diagnosed with cp, ms, stroke, spinal cord injury or other neurologic disorder that may cause such type of symptoms. * diagnosed \>6 months prior to inclusion in case of ms, stroke, or sci * give written informed consent * cognitively able to understand and follow verbal and/or written instructions * a minimum age of 2 years exclusion criteria: * any of the contraindications listed in the instructions for use of the exopulse mollii suit * being introduced to any new medication affecting the neuromuscular activity during the study period * using botulinum toxin \<3 month before or during the study period * subjects \<100 cm and \<13 kg * subjects \>205 cm and \>115 kg
steroid withdrawal in pediatric renal transplant: impact on growth, bone metabolism and acute rejection

Conditions: Kidney Diseases

Summary: the present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti il2 (interleukin 2), tacrolimus (tac) and mycophenolate mofetil (mmf). to investigate the impact of this protocol in growth, bone metabolism, insulin- sensitivity and evaluate the expression of il17 (interleukin 17) and mrna foxp3 (messenger ribonucleic acid forkhead box protein 3) as early markers of acute rejection (blood, urine and renal biopsy). hypothesis:steroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection. the expression of foxp3/il17 in urine cells could be an early molecular markers of acute rejection.

the intention of this investigation is to evaluate a prospective immunosuppressive protocol based on antibodies anti il-2 (ac-il-2), tacrolimus (tac) and mycophenolate mofetil (mmf)and withdrawal steroids in renal transplant and to compare with a steroid-based protocol. objectives: 1. to evaluate growth and the impairment in the gh/igf (growth hormone/insulin like growth factor) axis 2. to determine the impact of steroids on bone metabolism (biochemical parameters, dxa and pqct) 3. to determine the steroid effect on metabolic factors (dyslipidemia, insulin- sensitivity and arterial hypertension) 4. to determine acute rejection incidence (protocol renal biopsy) 5. to evaluate the expression of il-17 and mrna foxp3 as early markers of acute rejection (blood, urine and renal biopsy). two treatment regimes (arms)will be compared in randomized form in the course of 12 months after transplantation. arm a: tac + mmf + withdrawal of steroids over a six-days following randomization. arm b: tac + mmf + prednisolone (see schedule)/day

Eligibility criteria:
inclusion criteria: * age \< 16.0 years * bone age of boys \< 15 years, of girls \< 13 years * prepuberal tanner status i * first or second kidney transplant, living or deceased kidney donation * immunosuppression with tacrolimus (tac),mycophenolate mofetil (mmf) * patients and parents, respectively, have given their written consent after enlightenment (informed consent) exclusion criteria: * irreversible rejection of former transplant * highly reactive (\> 30%) lymphocytotoxic antibodies within 12 months prior to transplantation * suspected insufficient medication compliance in dialysis * patients receiving a basic immunosuppression other than that prescribed in this protocol * simultaneous therapy with growth hormone after renal transplant

Keywords: pediatric renal transplantation,bone metabolism (dxa-pqct) mrnafoxp3/il-17,steroid withdrawal
12-month, open-label, extension study of lcp-atorfen in dyslipidemia

Conditions: Dyslipidemia

Summary: the current study is designed to test the long-term (12-month) safety and efficacy of lcp-atorfen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

population: subjects with mixed dyslipidemia (non-hdl cholesterol \> 130 mg/dl and tg ≥ 150 mg/dl and ≤ 500 mg/dl) who completed the double-blind study (lcp-atorfen-2001; nct00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study. study design and duration: this is a 52-week, open-label, single-treatment arm with 8 visits (weeks 0, 4, 8, 12, 24, 36, 48 and 52). a maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the lcp atorfen-2001 double-blind study. all subjects enrolled in this study will receive open-label lcp-atorfen combination therapy. visit 1 of the extension study corresponds to the last visit of the double-blind study (visit 6 or week 12).

Eligibility criteria:
inclusion criteria: 1. subject has successfully completed the double-blind study (lcp-atorfen-2001; nct00504829). 2. subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with good clinical practice (gcp). exclusion criteria: 1. study drug compliance \<70% in the double-blind study. 2. any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug. 3. resting blood pressure \>/=160 mm hg systolic and/or \>/=100 mm hg diastolic. 4. symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis. 5. any clinically significant change in physical exam or electrocardiogram from visit 2 to visit 6 of the double-blind study. 6. any clinically significant change from visit 1 to visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (dm); poorly controlled dm; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy. 7. unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study. 8. women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception. 9. other exclusion conditions might apply.

Keywords: lcp-atorfen non-hdl cholesterol triglycerides hdl cholesterol ldl cholesterol atorvastatin fenofibrate
opportunistic screening in pharmacies for atrial fibrillation in seniors (>65 years)

Conditions: Incidence of Atrial Fibrillation in Adults Aged ≥ 65

Summary: atrial fibrillation (af) is the most common arrhythmia in germany and is associated with an increased risk of thromboembolic stroke. the risk to suffer from af increases with age. early detection of af and anticoagulation seem the most effective way of preventing ischaemic stroke in patients at risk. the guidelines of the european society of cardiology recommend opportunistic screening for af by pulse check at each general practitioner visit for all patients aged 65 years or older. the objective of this study was to test whether an opportunistic af screening with a hand-held diagnostic tool in a german pharmacy setting is useful in detecting unknown af among people in the age of 65 and older. besides a pulse palpation with a hand-held ecg-stick the screening in the pharmacies also includes a questionnaire related to demographics and medical history of the subject as well as several questions concerning the stroke risk stratification (cha₂ds₂-vasc). every subject with a positive test result (indication on af) is insistently asked to make an appointment with his or her general practitioner. the subject receives an information letter for his or her general practitioner that adverts to the positive screening result and the necessity of further diagnostic investigation. in order to assess the incidence of unknown af as well as accomplish the secondary objectives of this study, two follow-ups by means of telephone interviews are performed. first, all subjects with a positive test result are called 8 weeks after the screening in the pharmacies was conducted. the subject is asked several questions concerning personal data/demographics, the stroke risk (cha₂ds₂-vasc), the medical history regarding to dyspnea and stroke, the bleeding risk (has-bled), the medication, the device, diagnostic, the therapy, the intervention and the mace. 12 months after the screening in the pharmacies was performed, all participating subjects were called. the list of questions is similar to the one that is used during the first telephone interviews after eight weeks.


Eligibility criteria:
inclusion criteria: * at least 65 years or older * signed informed consent * signed subject information exclusion criteria: * insufficient language skills * limited cognitive abilities * limited physical abilities (i.e. tremor)

Keywords: atrial fibrillation screening electrocardiogram community pharmacy germany
genetics of asthma and bronchial hyperresponsiveness

Conditions: Asthma; Lung Diseases

Summary: to investigate the genetics of asthma by reexamining a carefully characterized population of patients with asthma, and by studying their families.

background: the development of asthma requires exposure to inciting agents such as allergens and environmental pollutants, as well as the presence of host or genetic factors. understanding the genetics of bronchial hyperresponsiveness (bhr) and allergy will delineate mechanisms that are important in the pathogenesis and therapy of asthma. while both genetic and environmental factors and their interactions are felt to be important, their precise role is not fully understood. design narrative: the probands are from the 'asthma' center beatrixoord in haren, the netherlands which was started in 1962. in collaboration with dr dirkje postma of holland, data are available on approximately 1200 patients who were first studied in 1963-1970 using the same protocol. family studies of the children and grandchildren of these original probands are underway. at this time, 85 complete families have been characterized and clinical data and dna are available for analysis in baltimore. families are being ascertained so that the investigators can test the fit of genetic models through segregation analyses. the major aim of the study is to identify major genes for bronchial hyperresponsiveness (bhr) and asthma by linkage with highly polymorphic dna markers. since allergy is commonly associated with asthma, a second goal of the study is to identify major genes for atopy using similar linkage studies. allergic factors under study include skin test reactivity to common allergens, serum total and specific ige levels, and blood eosinophilia. complex segregation analysis will be performed separately for asthma, bhr and allergy. the most parsimonious model from the segregation analysis will be used for linkage analysis. initially, candidate regions of the genome will be evaluated. then, a systematic search of the genome will be performed using highly polymorphic informative makers. when a linkage is detected, candidate genes in that specific area will be studied. the study was renewed in fy 1999 and in fy 2004 to: further characterize asthma and closely related phenotypes; perform genetic modeling (complex segregation analysis) using one and two locus models as well as bivariate segregation analysis; complete the genome wide screen; fine map regions of interest and identify candidate genes, perform linkage disequilibrium and haplotype sharing analyses; and perform case control analysis of susceptibility and severity candidate genes for asthma.

Eligibility criteria:
no eligibility criteria
safety and immunogenicity of hexavalent vaccine(dtwp-hepb-ipv-hib) in healthy infants

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b Infection

Summary: the purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of eupentatm inj. and imovax® polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine


Eligibility criteria:
inclusion criteria: 1. a male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination 2. born at full term pregnancy (gestational age ≥ 37 weeks) 3. body weight ≥ 3.2 kg at the time of screening 4. received one dose of hepatitis b mono-vaccine within seven days of birth 5. born to both hepatitis b virus surface antigen (hbsag) and human immunodeficiency virus (hiv) negative mother 6. subject's parent(s) or legally acceptable representative (lar) able to understand and comply with planned study procedures 7. written informed consent by subject's parent(s) or lar exclusion criteria: 1. previously received any dose of diphtheria, tetanus, pertussis, polio and/or hib containing vaccines 2. history of previous or concurrent vaccinations other than hepatitis b, bacillus calmette-guerin (bcg), rotavirus and pneumococcal vaccine 3. known or suspected history of diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, or hib diseases 4. household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis b, polio or hib diseases 5. experienced fever ≥ 38°c (100.4°f) within the past three days prior to screening 6. experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening 7. known or suspected immune disorder or immunodeficient condition 8. receipt of immunoglobulin or blood-derived product since birth 9. chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. for corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. inhaled and topical steroids are allowed. 10. history of bleeding disorder contraindicating intramuscular injection 11. major congenital defects or serious chronic illness 12. history of any neurological disorders or seizures 13. history of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin b, yeast or etc.) 14. history of allergic reactions to latex 15. participation in another interventional trial or received any investigational product within 30 days before to the enrollment 16. plan to leave the area of the study site before the end of the study period 17. infants who are considered unsuitable for the clinical study by the investigator
bipap in the management of acute respiratory distress syndrome

Conditions: Mechanical Ventilation Complication

Summary: evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ards as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.

biphasic positive airway pressure (bipap) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. bipap mode is pressure-limited and time-cycled, ventilation occurs via the time-cycled switching between two set pressure levels. in the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation. a proposed advantage of bipap compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching. ards is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance. in patients with ards, bipap with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. this is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit.

Eligibility criteria:
inclusion criteria: * all intubated adult ards patients * ards is diagnosed according to berlin criteria. exclusion criteria: * age \< 18 years. * cardiac or respiratory arrest on admission. * morbid obesity with bmi \> 40. * acute exacerbation of ipf. * cerebrovascular or neuro muscular disorder. 6. diabetic ketoacidosis. 7. hepatic or renal disease. 8.cardiac disease.

Keywords: bipap , ards
evaluation of the effectiveness of breathing control technique on long covid symptoms at the reunion university hospital

Conditions: Long COVID

Summary: despite the controversy, on october 6, 2021, the world health organization (who) recognized long coronavirus disease (covid) by officially defining it: " symptoms appeared 3 months after the onset of the primary infection by the severe acute respiratory syndrome coronavirus-2 (sars-cov-2), persisting for at least 2 months and which cannot be explained by any other condition ". long covid can affects any type of patient and has polymorphic and fluctuating symptoms over time. the reunion island is a french overseas department located in the indian ocean accounting more than 860,000 inhabitants. it has recorded since march 11, 2020, nearly 491,825 cases of covid-19 and 961 deaths of hospitalized patients. reunion's population is multi-ethnic and younger than the metropolitan france's one. it also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of covid-19. this specific context makes this island a particular study site for severe acute respiratory syndrome coronavirus-2 (sars-cov-2) and long covid. in addition, some studies have confirmed the involvement of the autonomic nervous system (ans) in the symptomatology of long covid and demonstrated that patients with a long covid present a dysfunction of their ans which is objectified by a reduced heart rate variability (hrv). the regulation of heart rate by the ans is strongly favored by respiration. a regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. the result of this training is an induced state called "cardiac coherence" (cc). the investigator therefore hypothesize that respiratory training to cc could "re-educate" the ans and durably improve the symptomatology of patients with long covid.


Eligibility criteria:
inclusion criteria: * patients over the age of 18, * living in reunion and * having a diagnosis of long covid according to the world health organization (who) definition will be included in this study. * these patients must attest to their primary infection with severe acute respiratory syndrome coronavirus-2 (sars-cov-2) and present a negative antigen test at the time of inclusion. exclusion criteria: patients: * with a chronic or disabling respiratory pathology preventing respiratory training (asthma, chronic obstructive pulmonary disease (copd), active tuberculosis, pulmonary sequelae of covid-19, etc.) practicing or having practiced a regular respiratory control technique (yoga, cardiac coherence training, etc.) in the last 6 months * taking a beta-blocker, betamimetic, anti-arrhythmic, morphine, antidepressant treatment (escitalopram) * having a pacemaker or severe heart disease * current and known pregnancy or breastfeeding woman * with a cognitive deficit * under guardianship/curators or under judicial protection
predictive value of pcle findings in pediatric ibd

Conditions: Inflammatory Bowel Disease

Summary: studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. it previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pcle) could be used to assess mucosal barrier function. furthermore, mucosal barrier dysfunction on pcle was shown to be predictive of disease relapse in adult ibd patients. the purpose of the current study is to determine the predictive value of pcle findings in pediatric ibd patients.


Eligibility criteria:
inclusion criteria: * signed informed consent * patients with established ibd exclusion criteria: * any kind of allergy * bronchial asthma * liver or kidney disease * inability to sign informed consent

Keywords: ibd pediatrics pcle